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Trial record 15 of 1012 for:    Area Under Curve AND insulin

SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance (SIT LESS 3)

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ClinicalTrials.gov Identifier: NCT02394249
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

Background of the study:

A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be spent. Several recent epidemiologic studies suggest that excessive sitting, independent of moderate to vigorous physical activity, has detrimental health effects. Another possibility to sit less is by increasing low intensity physical activities as slowly walking and standing. A recent published study of Duvivier and colleagues suggests that sitting less and replacing it by slowly walking and standing has a better effect on insulin action and cardiovascular risk factors than the combination of one hour MVPA per day and sitting the rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research is not performed in subjects with overweight/obesity.

Objective of the study:

To assess the effect of low intensity physical activity on plasma insulin levels, cognition and mood in subjects with overweight/obesity

Study population:

21 subjects between 40-80 years old with overweight/obesity

Intervention:

2 activity regimes of 4 days: a sitting regime and a "sit less" regime


Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Physical activity regime Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance
Study Start Date : February 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Sitting regime
The subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing and 8 hours sleeping.
Behavioral: Physical activity regime
Information already included in arm descriptions

Experimental: Sit Less regime
Subjects will follow the sit less regime during four days. Each day will consist of 9 hours sitting, 4 hours walking, 3 hours standing and 8 hours sleeping. The walking and standing will be done in a minimum of eight bouts with a time interval of >1 hour. The subjects will be instructed to walk on a slow pace, i.e. 2-3 km/h, which is comparable to walking during shopping, walking to the office etc.
Behavioral: Physical activity regime
Information already included in arm descriptions




Primary Outcome Measures :
  1. Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test) [ Time Frame: one day after each regime ]
    To assess the effect of low intensity physical activity (LIPA) on plasma insulin levels (as measured as area under the curve during an oral glucose tolerance test)


Secondary Outcome Measures :
  1. Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test) [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on insulin sensitivity

  2. Plasma C-peptide [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma C-peptide

  3. Plasma glucose levels [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma glucose levels

  4. Plasma triglycerides [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma triglycerides

  5. Plasma total cholesterol [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma total cholesterol

  6. Plasma non-HDL cholesterol [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma non-HDL cholesterol

  7. Plasma HDL cholesterol [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma HDL cholesterol

  8. Plasma LDL cholesterol [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma LDL cholesterol

  9. Plasma free fatty acids [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma free fatty acids

  10. Plasma apolipoprotein B [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma apolipoprotein B

  11. Plasma apolipoprotein A [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma apolipoprotein A

  12. Mood (measured by the Affect Grid mood scale) [ Time Frame: 2 days: last day of each regime and one day after each regime ]
    To assess the effect of LIPA on mood

  13. Attention (measured by the Attention Network Task) [ Time Frame: one day after each regime before and after the oral glucose tolerance test ]
    To assess the effect of LIPA on attention

  14. Executive Function (measured by the Trail Making Test) [ Time Frame: one day after each regime before and after the oral glucose tolerance test ]
    To assess the effect of LIPA on executive function

  15. Memory (measured by the Rey Auditory Verbal Learning Task) [ Time Frame: one day after each regime before and after the oral glucose tolerance test ]
    To assess the effect of LIPA on memory

  16. Quality of life (measured by the Gill 32-item questionnaire) [ Time Frame: last day of each regime ]
    To assess the effect of LIPA on quality of life

  17. Sleep (measured by the 10-item Pittsburgh Sleep Quality Index) [ Time Frame: last day of each regime ]
    To assess the effect of LIPA on sleep

  18. Plasma C-reactive protein [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma C-reactive protein

  19. Plasma interleukin 1 [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma interleukin 1

  20. Plasma interleukin 6 [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma interleukin 6

  21. Plasma TNF-alpha [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma TNF-alpha

  22. Plasma interferon gamma [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma interferon gamma

  23. Plasma ICAM-1 [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma ICAM-1

  24. Plasma VCAM [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma VCAM

  25. Plasma serum amyloid A (SAA) [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma SAA

  26. Plasma E-selectine [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma E-selectine

  27. Plasma von Willebrand factor (vWF) [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma vWF

  28. Plasma PAI-1 [ Time Frame: one day after each regime ]
    To assess the effect of LIPA on plasma PAI-1

  29. To explore the association between plasma glucose, plasma insulin, insulin sensitivity and mood, cognitive performance, quality of life and sleep [ Time Frame: one day after each regime ]
  30. Blood pressure [ Time Frame: one day after each regime ]
  31. Heart rate [ Time Frame: one day after each regime ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Men and postmenopausal women: 40-80 years old
  • BMI: 25.0 - 35.0 kg/m2
  • Maximum 2.5 hours of MVPA per week (during last 3 months)
  • Having a general practitioner
  • Agreeing to be informed about medically relevant personal test-results by a physician
  • Accessible veins on arms as determined by examination at screening

Exclusion Criteria:

  • Reported participation in another biomedical trial which may have an effect on insulin sensitivity one month before the pre-study examination or during the study
  • Blood donation in the past three months
  • Reported participation in night shift work 2 weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
  • Consumption of >14 (women) or > 21 (men) alcoholic units per week
  • Reported dietary habits: medically prescribed diet, slimming diet;
  • Reported weight loss (>2kg) in the last three months prior to the screening;
  • Not being able to execute at least three (out of four) cognition tests in the training session
  • Not being able to execute the sit less try-out day
  • Being an employee of Unilever or the collaborating research departments in Maastricht University Medical Centre
  • Experimental drug use (during the last 3 months)
  • Use of insulin, oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors), corticosteroids or vitamin K antagonists in the last 3 months
  • Fasting plasma glucose level > 6.9 mmol/L
  • Medical conditions which make participation in the study not responsible which will be decided by a medical doctor during screening
  • Other clinically relevant abnormalities in clinical chemistry at screening (to be judged by a medical doctor)
  • Mental or physical disability which interferes with physical activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394249


Locations
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Netherlands
Human Movement Science, Maastricht University
Maastricht, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University Medical Center
Unilever R&D
Investigators
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Principal Investigator: Hans H Savelberg, PhD Maastricht University Hospital

Additional Information:
Publications:
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02394249     History of Changes
Other Study ID Numbers: 143046
NL50688.068.14 ( Registry Identifier: Medical Ethical Committee Maastricht University Hospital / University of Maastricht )
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Maastricht University Medical Center:
Insulin Resistance
Cognition
Affect
Insulin
Lipids

Additional relevant MeSH terms:
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Insulin Resistance
Insulin
Insulin, Globin Zinc
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs